0.9% SODIUM CHLORIDE INJECTION 0.9% sodium chloride 20 mL solution for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium chloride, Quantity: 0.18 g

Available from:

B Braun Australia Pty Ltd

INN (International Name):

Sodium chloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous, Subcutaneous

Units in package:

20 x 20 ml

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Solvent or diluent for compatible electrolyte concentrates or drugs.

Product summary:

Visual Identification: Clear to colourless solution; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-04-16

Patient Information leaflet

B.Braun Australia Pty Ltd
Page 1
CONSUMER MEDICINE INFORMATION
B. BRAUN 0.9% SODIUM CHLORIDE INJECTION
_THIS LEAFLET PROVIDES A SUMMARY OF SOME OF THE IMPORTANT THINGS YOU
NEED TO KNOW ABOUT THIS _
_MEDICINE. ONLY YOUR DOCTOR AND PHARMACIST ARE ABLE TO WEIGH UP ALL
THE RELEVANT FACTS ABOUT THE _
_USE OF THIS MEDICINE IN YOUR CONDITION AND YOU SHOULD CONSULT THEM
FOR FURTHER DETAILS. MORE _
_DETAILED AND TECHNICAL INFORMATION IS AVAILABLE ON REQUEST FROM YOUR
DOCTOR OR PHARMACIST. _
The solution is a clear colourless solution intended for intravenous
or subcutaneous injection.
Composition:
100 mL of solution contains:
Sodium Chloride
0.90 g
_Electrolyte concentrations:_
Sodium
154 mmol/L
Chloride
154 mmol/L
Theoretical osmolarity
308 mOsm/L
Titration acidity
< 0.3 mmol/L
pH:
4.5 – 7.0
WHAT IS THE PRODUCT USED FOR?
It is used as a solvent or diluent for compatible electrolyte
concentrates or drugs.
BEFORE USING THIS PRODUCT:
Please note that the solution should not be used if the container is
found
to be leaking or the solution is not clear.
DIRECTIONS FOR USE:
This product has been chosen by your doctor and will be given to you
as an
intravenous or subcutaneous injection.
The quantity to be used depends on the desired concentration of the
medicament to be dissolved.
For
the
use
of
this
solution
as
solvent/diluent
for
compatible
electrolyte
concentrates
or
medicaments, the instructions for use relating to the medicament to be
added should be observed
.
UNWANTED EFFECTS:
None to be expected if the product is used according to directions.
B.Braun Australia Pty Ltd
Page 2
OVERDOSAGE:
Overdose of 0.9 % sodium chloride solution may result in
hypernatraemia,
hyperchloraemia, hyperhydration, hyperosmolarity of the serum, and
metabolic acidosis.
Emergency treatment, antidotes
Immediate stop of administration, administration of diuretics with
continuous monitoring of serum
electrolytes, correction of electrolyte and acid-base imbalances.
STORAGE CONDITIONS:
The solutions should be stored in a cool place, below 25
0
C and

Summary of Product characteristics

NaCl Inj. PI – Version 3.0 (12/08/2022)
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AUSTRALIAN PRODUCT INFORMATION
B. BRAUN 0.9% SODIUM CHLORIDE INJECTION
1.
NAME OF THE MEDICINE
Sodium Chloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100 mL of the 0.9% sodium chloride solution for injection contains:
Sodium Chloride
0.90 g
_Electrolyte concentrations: _
Sodium
154 mmol/L
Chloride
154 mmol/L
Theoretical osmolarity
308 mOsm/L
Titration acidity
< 0.3 mmol/L
pH:
4.5 – 7.0
3.
PHARMACEUTICAL FORM
Clear to colourless solution for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solvent or diluent for compatible electrolyte concentrates or drugs.
4.2 DOSE AND METHOD OF ADMINISTRATION
The quantity to be chosen depends on the desired concentration of the
medicament to
be dissolved. For the use of this solution as solvent/diluent for
compatible electrolyte
concentrates or medicaments, the instructions for use relating to the
medicament to be
added must be observed.
METHOD OF ADMINISTRATION
Intravenous or subcutaneous injection.
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4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
0.9% Sodium Chloride Injection should only be administered with
caution in cases of
hypernatraemia and hyperchloraemia.
USE IN THE ELDERLY
No data available.
PAEDIATRIC USE
No data available.
EFFECTS ON LABORATORY TESTS
No data available.
4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF
INTERACTIONS
None known.
When mixing with other medicaments, possible incompatibilities should
be
considered.
4.6 FERTILITY, PREGNANCY AND LACTATION
EFFECTS ON FERTILITY
No data available.
USE IN PREGNANCY
0.9% Sodium Chloride Injection can be used as indicated.
USE IN LACTATION
0.9% Sodium Chloride Injection can be used as indicated.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
The effects of this medicine on a person's ability to drive and use
machines were not
assessed as part of its registration.
4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)
No data available.
NaCl Inj. PI – Version 3.0 (